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A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer

Last updated on March 26, 2019

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Study Location
Georgetown University Medical Center
Washington, District of Columbia, 20007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Histologically or cytologically confirmed advanced RCC with predominantly clear-cell
subtype with primary tumor resected

- At least one measureable lesion as defined by Response Evaluation Criteria In Solid
Tumors (RECIST) version 1.1.

- Eastern Cooperative Oncology Group performance status 0 or 1

- Controlled hypertension

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Prior treatment with systemic therapy for advanced RCC

- Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred
during or within 12 months after the last dose of treatment

- Prior treatment with any agent specifically targeting T-cell co-stimulation or
checkpoint pathways

- Active seizure disorder or evidence of brain metastases, spinal cord compression, or
carcinomatous meningitis

- Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of
randomization except for adequately treated basal cell or squamous cell skin cancer,
or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with
no plans for treatment intervention

- In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident,
or transient ischemic attack

- In past 6 months: deep vein thrombosis or pulmonary embolism

NCT02133742
Pfizer
Active, not recruiting
A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer

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[email protected]

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